From April 19, 2011 to June 03, 2011, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 5475 115th Ave. N, Clearwater, Florida. Our investigation revealed significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulation for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). At the conclusion of the inspection, you were issued a Form FDA 483, List of Inspectional Observations, which lists a number of the violations that cause the products manufactured in your facility to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that these dietary supplements have been prepared, packed, or held under conditions that do not meet current good manufacturing practice requirements for dietary supplements. You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.

The inspection revealed the following violations:

1. Your firm failed to verify that your finished batch of dietary supplements met established product specifications for purity and strength, as required by 21 CFR 111.75(c). You must establish product specifications for each dietary supplement you manufacture (21 CFR 111.70(e)), and determine whether these specifications are met (21 CFR 111.73) by testing the finished batch of dietary supplement in accordance with testing requirements in 21 CFR 111.75(c). Specifically, you provided our investigator with finished assay test data on the products you manufacture, including assay data on product FaBB (batch# 030013 and 030014). However, our review of the assay data revealed that they were insufficient to meet this requirement. Your assay data did not provide quantitative data to determine if the specifications for your finished products were met. Further, the concentration (strength) for the referenced standards was not provided.

We reviewed your response and exhibits 1-4 dated June 23, 2011 and found it to be inadequate. You submitted a standard operating procedure (SOP) entitled “Minimum Finished Product Testing Requirements for Nutritional Product.” However, this SOP appears to only address the identity requirement. It does not address your responsibility to verify the purity, strength, and composition specifications of your finished products. You also submitted finished product specification sheets for the products Kidney Cleanse, Liver Cleanse, Slim System, and Natural Moves. However, these product specification sheets do not list the required specifications under 21 CFR 111.70(e).

2. You failed to establish laboratory control processes that are reviewed and approved by quality control personnel, including the use of criteria for selecting reference materials used in performing tests and examination, as required by 21 CFR 111.315(d). Specifically, you indicated to our investigators during the inspection that your non-compendia reference standard materials (i.e., spectrum graphs) for the (b)(4) transform infrared spectroscopy ((b)(4)TIR) are selected from previous component shipments received and analyzed by your (b)(4)TIR equipment. However, you failed to establish any criteria (i.e., characterization) to establish a reference standard. Non-compendia reference standard materials should be of the highest purity by reasonable effort and should be thoroughly characterized to ensure their identity, purity, quality, and strength.[OGC1]

We reviewed your June 23, 2011 response and you did not further address the investigator’s observation regarding the (b)(4)TIR scan.

3. You reprocessed dietary supplements, but failed to have quality control personnel conduct a material review and make a disposition decision that is based on a scientifically valid reason and approve the reprocessing, as required by 21 CFR 111.90(b)(1). The person who conducts a material review and makes the disposition decision must document that at the time of performance [21 CFR 111.113(b)(2)], and you are required to make and keep these records [21 CFR 111.140(b)(3)]. Specifically, you were unable to produce documentation that quality control personnel conducted a material review, made a disposition decision, and approved the reprocessing of the following:

Slim System tablets, batch # 020194, failed its tablet specifications (e.g., hardness) due to “flow” issues during tablet compression and the product was reprocessed. You indicated to our investigators that the product was reprocessed by a process called (b)(4)

We reviewed your response and exhibits dated June 23, 2011 and found it to be inadequate. You submitted a blank “(b)(4) form,” as an exhibit, but it does not specifically correct this violation. Further, you provided no documentation to show a material review and disposition decision prior to any reprocessing of the dietary supplements.

4. Your firm's batch production records do not include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 111.260. For example, the batch records for Zen Cleanse Liver Cleanser (batch # 020336), Zen Cleanse Kidney Cleanser (batch # 120005), Prostate Men’s Health (batch # 020321), Vita Trum SR (batch #020371), and Vita-TRUM 50 + (batch # 020268) lack the batch production information related to the tablet coating of these products. Your Master Formula for these products indicated that these tablets were coated and that some were outsourced for coating. However, there is no information in your batch records to show the coating process of these tablets.

We reviewed your response dated June 23, 2011 and found it to be inadequate. You did not include any procedure or documentation on how these products were coated.

5. Your firm did not establish specifications for each component that you use in the manufacture of your dietary supplements, including (1) an identity specification; (2) component specifications that are necessary to ensure that specifications that are necessary to ensure that the specifications for the purity, strength and composition of dietary supplements manufactured using the components are met; and (3) limits on those types of contamination that may adulterate or may lead to adulteration on the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required in 21 CFR 111.70(b). For example, your firm failed to establish identity, purity, strength, and composition specifications for the Vitamin A Acetate 500,000 IU (ION Labs Raw Material Test Ticket date received 1/17/11) and Choline Bitartrate (ION Labs Raw Material Test Ticket date received 9/9/10) used in the manufacture of your dietary supplements. These Test Tickets list some tests and specifications, but the specifications listed did not meet the requirements under 21 CFR 111.70(b) for the purity and composition specifications of the components, and, as applicable, limits on the types of contamination that may adulterate or may lead to adulteration of the finished products.

We reviewed your June 23, 2011 response and exhibits 7-10 and found them to be inadequate. For example, we reviewed your raw material specification sheets for magnesium stearate and isomalt. Based on our review, your firm failed to establish the identity, purity, strength, and composition specifications for these components you use to manufacture your dietary supplements.

6. Your quality control personnel failed to conduct a material review and make a disposition decision when a batch deviates from the master manufacturing record (MMR), including when any step established in the master manufacturing record is not completed and including deviations from specifications as required by 21 CFR 111.113(a)(2). You are required to make and keep documentation of any material review and disposition decision and follow-up [21 CFR 111.140(b)(3)]. Such documentation must meet the requirements of 21 CFR 111.140(b)(3), including an identification of the specific deviation or the unanticipated occurrence [21 CFR 111.140(b)(3)(i)]; a description of your investigation into the cause of the deviation from the specification or the unanticipated occurrence [21 CFR 111.140(b)(3)(ii)]; an evaluation of whether or not the deviation or unexpected occurrence has resulted in or could lead to a failure to ensure the quality of the dietary supplement [21 CFR 11.140(b)(3)(iii)]; the identification of the actions taken to correct, and prevent a recurrence of, the deviation or unanticipated occurrence [21 CPR 111.140(b)(3)(iv); an explanation of what you did with the component, dietary supplement, packaging, or label [21 CFR 111.140(b)(3)(v)]; and a scientifically valid reason for any reprocessing of a dietary supplement that is rejected or any treatment or in-process adjustment of a component that is rejected [21 CFR 111.140(b)(3)(vi)].

Specifically, the following batches deviated from the MMR, and you did not provide documentation of any material review and disposition decision and follow up for these deviations.:

Natural Moves, batch # 020331 deviated from the MMR in that calcium carbonate was added to the batch, but not part of the MMR. Also, additional amounts of microcrystalline cellulose were added beyond the amount listed in the MMR.

Wintergreen ContentMints, batch # 020305 deviated from the MMR in that additional amount of 1% of Magnesium Stearate Powder was added to the batch.

7. When a dietary supplement does not meet a specification established in accordance with 21 CFR 111.70(a), quality control personnel must reject the dietary supplement, unless quality control personnel approve a treatment, an in-process adjustment, or reprocessing, as permitted in 21 CFR 111.77 [21 CFR 111.77(a) and 111.113(b)(2)]. However, your firm's quality control personnel approved the release of the following finished batches of product that did not meet specifications established under 111.70(a):

We reviewed your June 23, 2011 response to Observation 4 and found it to be inadequate. Your response addressed that you will re-train your quality control personnel on Out of Specification procedures, but it did not address why your quality control personnel did not reject out of specification products.

We reviewed your response dated June 23, 2011 and found it to be inadequate. You did not include documentation of any material review and disposition decision regarding these deviations.

A statement of the expected yield of the manufactured dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted, and disposition decision is made. [21 CFR 111.210(f)].

A description of packaging and a representative label or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)].

Written instructions, including:

oSpecifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR [21 CFR 111.210(h (1)]. Specifically, these tablets products are coated, but there are no coating specifications (e.g., coating type) listed in your master formula.

oProcedures for sampling and a cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2)].

oWritten instructions, including specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record [21 CFR 111.210(h)(3)].

oCorrective action plans for use when a specification is not met [21 CFR 111.210(h)(5)].

This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment and the products you market comply with the Act and its implementing regulations.

Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.

Please advice this office in writing within 15 days from your receipt of this letter of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not recur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, explain the reason for the delay and the date by which you will complete the corrections.

Your response should be sent to: Winston R. Alejo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions about the content of this letter please contact: Mr. Alejo at (407) 475-4731.

Sincerely,

/S/

Emma R. Singleton

Director, Florida District

[OGC1]Rephrased as “should” because this is not required in the regulation.